Virtual Reality and Field Training to Enhance Community Walking After Stroke

NCT04559373 | Recruiting

• 1 other identifier: PJT-148917
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

While stroke survivors discharged from rehabilitation present with some recovery in mobility, their ability to ambulate in the community remains limited. The investigators propose to test a novel, low-cost, intensive and individually tailored intervention that combines virtual reality (VR) and field training to enhance community ambulation and participation in stroke survivors discharged from rehabilitation. The aims are to: (1) Assess feasibility, acceptability, safety and adherence of the intervention in stroke survivors; and (2) Examine the extent to which post-intervention changes in functional walking and participation to community walking vary according to walking, cognitive and visual-perceptual abilities. The investigators will use a virtual environment prototype simulating a shopping mall and surrounding streets, in which participants will interact using VR goggles and game controllers. Scenarios of increasing levels of complexity will be introduced. This intervention study involves a single group, multiple pre- multiple post- study design where chronic stroke participants will engage in a 4-week training program. The program will include VR training sessions performed in the clinical setting (3/week) and practice of community ambulation skills while supervised by family/caregivers (2/week). Participants will be assessed on measures of functional walking, balance \& mobility and participation to community walking. Adherence, safety and acceptability will be documented. This study will generate foundation knowledge on the response to the intervention based on individual capacities.

Conditions

Stroke

Keywords

Aging; Biomechanics; Community ambulation; Intervention; Locomotion; Rehabilitation; Sensorimotor integration; Virtual reality

Outcome Measures

Primary Outcomes (2)

• Post-intervention change in the Six Minute Walk Test (6MWT)

  The six-minute walk test measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway.

  Pre-intervention (Week4) and post-intervention (Week8)

• Change in the Six Minute Walk Test (6MWT) at Follow-up

  The six-minute walk test measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway.

  Post-intervention (Week8) and Follow-up (Week12)

Secondary Outcomes (6)

• Dynamic Gait Index

  Baseline (Week0), pre-intervention (Week4), post-intervention (Week8) and follow-up (Week12)

• 5m Walk Test

  Baseline (Week0), pre-intervention (Week4), post-intervention (Week8) and follow-up (Week12)

• Activities-Specific Balance Confidence Scale

  Baseline (Week0), pre-intervention (Week4), post-intervention (Week8) and follow-up (Week12)

• Trip Activity Log

  Baseline (Week0), pre-intervention (Week4), post-intervention (Week8) and follow-up (Week12)

• Environmental Analysis of Mobility Questionnaire

  Baseline (Week0), pre-intervention (Week4), post-intervention (Week8) and follow-up (Week12)

Other Outcomes (8)

• Adherence to intervention

  3x/week over the 4-week intervention for the virtual reality component; 2x/week over the 4-week intervention for the field training component

• Safety of the intervention

  3x/week over the 4-week intervention of the virtual reality component

• Acceptability of the intervention

  Post-intervention (Week8)

Study Arms (1)

Virtual Reality and Field Practice Training (VRFT)

EXPERIMENTAL

Participants will engage in a 4-week VRFT intervention that comprises of 1-hour training sessions, 3 times/week.

Other: Virtual Reality and Field Training (VRFT)

Interventions

Virtual Reality and Field Training (VRFT) OTHER

The VRFT intervention involves the intensive practice of community ambulation skills. Some of the training sessions will be performed in a virtual environment, while others will consist of field training exercises in the community. During the intervention, stroke participants will be invited to practice different dimensions of community ambulation, such as postural transitions, avoiding other pedestrians, dual-task walking, etc.

Virtual Reality and Field Practice Training (VRFT)

Eligibility Criteria

• Age: 40 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• People with chronic stroke and persistent deficits in walking / visual-perceptual / cognitive capacities. They can be male or female, aged from 40 to 74 years, with normal/corrected visual and auditory acuity, and present with:
• First-ever supratentorial unilateral stroke 9-24 months ago (such chronicity will ensure steady-state mobility without long-term disuse-related changes
• Mild-to-moderate hemiparesis (Chedoke McMaster Stoke Assessment stages 4/7-6/7 on postural control, leg \& foot)
• Ability to walk independently with/without walking aids for at least 1 min at 0.4-0.9 m/s (such a speed range indicates mobility not sufficient for functional community ambulation: shopping \~1.1m/s, street crossing \~1.2 m/s)
• Intact or mildly affected cognitive function (Montreal Cognitive Assessment scores ≥ 22/30)
• Intact to moderately affected visual-perceptual function (positive scores on a maximum of 3/6 tasks on the Behavioural Inattention Test)

You may not qualify if:

• Subjects with comorbidities interfering with walking
• Subjects with comorbidities interfering with visual perception
• Subjects without medical clearance for exercise

Sponsors & Collaborators

• McGill University: lead
• Jewish Rehabilitation Hospital: collaborator
• Integrated University Health and Social Services Center of the Capitale-Nationale: collaborator
• Laval University: collaborator

Study Sites (2)

Jewish Rehabilitation Hospital

Laval, Quebec, H7V1R2, Canada

RECRUITING

Institut de réadaptation en déficience physique de Québec

Québec, Quebec, G1W 1P7, Canada

NOT YET RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Anouk Lamontagne, PhD

  McGill University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anouk Lamontagne, PhD

CONTACT

514-938-4397; anouk.lamontagne@mcgill.ca

Andréanne Blanchette, PhD

CONTACT

418-656-2131; andreanne.blanchette@fmed.ulaval.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Intervention study involving a single group, multiple-pre, multiple-post, sequential design.

Study Record Dates

• First Submitted: July 6, 2020
• First Posted: September 22, 2020
• Study Start: April 1, 2021
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be available within 6 months of study completion
• Access Criteria: De-identified data will be deposited in a REDCap database and made available to collaborators. Data may also be made available to other researchers via an institutional data repository that will allow adhering to FAIR principles.

Locations

CA (2)